FDA approves a Chiesi Global Rare Diseases and Protalix BioTherapeutics BLA for Elfabrio (pegunigalsidase alfa-iwxj) for treating adult patients with ...
An FDA advisory committee recommends the approval of a Laboratoire HRA Pharma NDA seeking a prescription-to-nonprescription switch of its Opill, a nor...
FDA clears a Hubly Surgical 510(k) for the Hubly Drill and its use in performing burr hole procedures as part of brain surgery.
FDA announces a joint project with the National Institute of Standards and Technology to develop resources needed by animal biotechnology developers.
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Somscans Detectnet (copper Cu-64 dotatate...
FDA publishes an immediately-effective guidance to help drug manufacturers, repackers, and compounders prevent the use of glycol-contaminated glycerin...
Federal Register notice: FDA sends to OMB an information collection revision entitled Expanded Access to Investigational Drugs for Treatment Use.
FDA warns Carlsbad, CA-based Premier Nutra Pharma about CGMP violations in its work as a contract drug manufacturer.
